Q2 2023 PDS Biotechnology Corp Earnings Call
Our cash and cash equivalents as of June 32023 totaled approximately $66 million and based on the company's cash resources and projections. We believe this balance is sufficient to fund operations and our research and development and clinical programs for the 12 months following the filing of.
At June 20th twenty-three quarterly report on Form 10-Q, which will be filed today. We can eat continue to be engaged in business development opportunities and we'll continue to manage our cash prudently. This.
This completes my discussion and at this time I would like to hand, the call back to the operator for the Q&A session operator.
You will now be conducting a question and answer session if you'd like to be placed in the question queue. Please press star one on your telephone keypad you May press star two if you'd like to move to a question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing star one one moment. Please while we poll for questions. Our first question.
Today is coming from Joe Pan Janus from H C. Wainwright. Your line is now live.
Good morning, everyone. Thanks for taking the question and happy summer.
So first just wanted to get a sense of the operational readiness for the phase III I mean fourth quarter is not too far away. So obviously everything's probably.
All set wanted to get a sense of what the target enrollment is.
The randomization is it one to one.
Assuming the supplies all ready to go the diagnostic and then of course Loren already discussed the benchmarks will start with that thanks a lot.
Okay.
Hey, Joe Thanks, a lot for your question.
With respect to the operational readiness as we know there are a number of things that have to happen beyond just the submission of the IND.
The amendment and updates to the R&D and number of those are actually actively ongoing currently we have to activate the clinical sites were currently looking at as Lauren said at 90 to 100 clinical sites.
In the process of getting those sites up.
Up and running we have had very good response higher than expected, we actually have about a 100 clinical sites, who have already indicated interest in participating in the phase III data and we believe that is directly directly related to the data that was presented at <unk>. The overall survival as well as the safety as you know I'm heading.
That comes down call. It just not really looking for something that can help their patients live longer with higher quality of life, that's well tolerated. So we believe that's really.
Largely responsible for the.
Larger than larger than expected interest that we've seen in these clinical sites are really getting all the sites up and ready and waiting for the Green light from the FDA and then we actually have to start getting the investor Institutional review boards at the various sites to also approve these trials. The good thing is that in terms of manufacturing the manufacturing is done the product.
It's been manufactured and so all of that information is what was utilized to update the CMC section.
When we're looking at the target enrollment up anywhere between.
I would say between 200 to 300 patients pending we are waiting for the final feedback from the FDA right. Now. So you know we submitted those documents last week because of R&D and so once we have the final green light or any feedback from the FDA. We can then make that final after the final protocol.
Available to everyone, but we we've submitted what we anticipate could be the final protocol, but we always want to wait to get that feedback before we say this is the absolute final protocol back some moving into the phase three trial, but so far we have we are very pleased and we are excited to get this going and we think this is a really solid critical that was developed based upon inputs that.
We received from the FDA. So we are actually all of the fda's feedback into consideration and putting this critical together.
To be a controlled trial right and with Keytruda as the control control arm.
That's very helpful. Frank Thank you for that and then I guess, just maybe quickly on the <unk> 301 study with Docetaxel very intriguing and I was just curious.
What are the levels of translational data that youre looking to gather for that study and then also I guess you know talking to the the.
The immune approach in combination with Docetaxel I guess, maybe you were Lorne can discuss sort of the approach that you're taking here because even going back years ago with.
Data out of the Gullion slum labs that talked about you know the bench.
Benefit or lack thereof, or what's best to do with regard to say concomitant dosing with docetaxel or sequencing or what have you. So looking to get more info on the.
Translational info and then and then lastly, just curious since it's.
Not discussed today, but it's always in the forefront of People's minds in the World is what's percolating in the background with regard to influenza. Thanks a lot.
Really good questions, Joe So I'll address the influenza and then ill hand, it over to Lauren to address the translational studies with PD <unk> 301.
With the flu program. This program continues to progress under the N I E I D Civics program.
If you're lucky enough as typical with flu vaccines.
The successful mountain study. The vaccines are then you can be tested and ferrets and ferrets are considered the gold standard and the most relevant to human human results. So these studies and Paris are currently ongoing with P. D. S O to O two.
<unk> selected centers and so based upon what's going on now in both Paris Studies, we will we do intend to provide an update when these results are available and also once the clinical studies are confirmed by and I E. I D. So those studies are continuing to progress.
Hey, Lauren I'll hand over to you to discuss the translational studies for P. D. S O 301.
<unk> with Docetaxel in the Gulf.
Great. Good morning, and thanks for your question Joe. So your question is an excellent one and one of the things that's coming out of Doctor Megami study is there's actually concurrent dosing of P. D. S. O 301, and Docetaxel specifically, there's also examination of different dose levels.
P D. S O 301 in the Docetaxel combination and they're looking at both metastatic castration sensitive as well as castration resistant prostate cancer.
The translational relevance here is is that we really want to one ensure the safety of the code delivery of the combination together.
More importantly, since NHS IL 12 is a tumor targeting immuno cytokine, we really wanted to see if there are differences in terms of the magnitude of immune responses and clinical outcomes that we see with different doses when it's deliberate in combination with docetaxel.
Our hope is is that since we know docetaxel induces tumor necrosis that code delivery a P. D. S. O 301 could actually augment this tumor necrosis from a translational standpoint, our interest is not only in the fact that PD escrow 301 is a tumor targeting T cell immune cytokines.
That we see augmentation of these tumor specific T cell responses, but also the possibility of augmenting natural killer cell responses to this combination therapy. So we're really looking forward to a doctor and mcdonalds presentation.
A cytokine <unk> 2023.
And this would lead to bill.
Building on further studies once we know what we see as far as the clinical outcomes and the immune responses.
Great. Thanks for all the color.
Thank you next question today is coming from Louise Chen from Cantor Fitzgerald. Your line is now live.
Hi, Good morning, and thank you for taking my questions and congratulations on the quarter. This is Lucas Stephanie on for Louise Chen from Cantor.
Two quick questions I guess, they're more big picture strategy Slash vision question. So first question is with regards to your verse immune platform. So you've had a lot of success to date leveraging it with PDL one O y O.
102.
Three or four et cetera.
So it just like what is your vision for the future developing the platform or how do you hope to expand on the platform success to date and then the second question is if you could talk a little about your partnership with the NIH and if there's any like important developments there or how you see that progressing moving forward. Thank you.
Yeah.
Thanks, a lot two two very good questions. So the first immune platform is first be developed with them with PD. So 101, <unk> hundred one we really see us.
Roof, a concept study for the platform.
Just based upon what's happened with the T cell activating technologies over the last couple of decades. We believe it's very important question really demonstrated this proof.
Strong proof of concept for the industry to really understand the potential of PD. One one to one so as you know we've also perform preclinical studies with PD, one or two which is nice.
The same platform.
In.
T. A R. P specific tumor so at least with address prostate cancer and breast cancer.
We've also performed those preclinical studies with PD is a 103 that addressed as Marc one positive, Kansas visa, Kansas like ovarian cancer, non small cell lung cancer breast cancer and colon cancer and in preclinical studies, we have demonstrated that we can generate the same levels of multi function.
No killer T tumor targeted killer T cells with each of these products right. So still really with the PD 101 now our goal is really to get this rapidly into commercialization P. D. S. 0101, as you know I'm presses all types of HPV associated cancers. However, we have an initial fee.
Focus on head and neck cancer, which is the largest and most rapidly growing obese HPV indications.
Indications right so.
As I mentioned I think on the last call we had a meeting with the FDA regarding the triple combination, which we intend to also move initially into head and neck cancer. We also have the studies ongoing currently.
Your clinic, which is looking at early stage.
That's a new adjuvant treatment in.
Patients who have oral cancer ahead of their M C.
Surgical removal of the lesions. So we're really looking to position strongly position P. D. S 0101, which is the frozen burst mean based product.
As a therapy for head and neck cancers right from early stage treatment all the way through recurrent metastatic in checkpoint refractory patients. We want P. D. S 0101 to be synonymous with head and neck cancer treatment and we believe based on our partnerships with the National Cancer Institute, what we do with Mayo clinic that we will be able to.
Successfully achieve this we then also as you know haven't started studies in cervical cancer. The National Cancer Institute actually looked at all types of HPV associated cancers. So we have very strong evidence that P. D. S. O 101 has potential far beyond just head and neck cancer, but broadly applied in HPV associated cancers.
As I mentioned this is the proof of concept study and we do intend to move <unk>, Oh, two or one or two and a one O suite also rapidly into the clinic Pdfs a 103 as we mentioned on this call we intend to file the IND for PD is a 103, which addresses Mach one related cancers.
Mark one mark one positive cancers to allow them to also go into the clinic after that so.
That would be the second product coming off the Pds a y O Y to one and also we also have a business development strategy right. So we were looking to selectively and advantageously.
Some of these programs to move them rapidly into the commercialization path right and so moving on to the second question you asked which is our partnerships with the NIH. So I think one of the key things that doesn't really become very obvious.
Very often is the importance of the partnership with the National Cancer Institute partnerships with folks like MD Anderson and Mayo clinic. These partnerships have come about after several years of many of these partners actually independently in preclinical studies.
In our technology.
Completely independent of Pds and convincing themselves that this these technologies, our <unk> technology as well as Pete <unk>, our tumor antibody conjugated IL 12 has the potential to significantly advance the science of clinical oncology.
These <unk>.
Experts are looking for.
Technologies that can advance clinical science, they're going to do this that is completely independent of what P. D. S is thinking so.
<unk> Oh, what P. B S wants to see you still compete yes. Its perspective, we have to have enough confidence in our science and our technology that when we had our technology over to experts such as the NIH M D Anderson and Mayo clinic.
But we are comfortable with them reporting what offer they find regarding our technology and our science.
And so far as we can see from the results.
They have provided strong validation independent validation of the science and technology and the interest of these but these experts and key opinion leaders and actually transfer.
Transitioning this into from preclinical studies into human clinical trials and being interested in putting some of their own capital into progressing these trials.
Very strong validation of the science and the opinion of the key experts that this has the potential to significantly advance the science of clinical oncology.
To date, we have eight phase two clinical trials ongoing.
And five for five of these trials are partnered with the National Cancer Institute.
So what you can see here is that based upon.
These partnerships and this buy in to the science. The P. D. S. Biotechnology is developing we are able to progress a lot more clinical trials than we typically would.
Significantly lower cost to Pts by technology.
We were able to really advance these programs and what this allows us to do now is.
As to understand how.
P. S. O 301 for example are tumor targeted IL 12.
Case in certain solid tumors, how it how it synergizes with standard of care technologies for example, with dealing with chemotherapy Docetaxel Wilson looking at combinations with radiation, we're looking at monotherapy and.
And we're doing the same with a triple combination. So this allows US then to look at the phase two data.
And in which combinations in which indications we have the best chance to rapidly commercialize these products. So we see this relationship with the National Cancer Institute, that's a really strong validation.
They are key experts in these skills and they also provide P. D S with a lot of expert oversight and guidance in terms of how we designed these trials and all things what specific indications we look for what they have seen this almost every technology. That's been successful oncology hop back you had gone through the National Cancer Institute the bedroom probable.
Relationship to PDF biotechnology.
Okay. Thank you very much for the answers and the color.
Follow up questions for me. Thank you.
Youre welcome.
Thank you next question is coming from carpet Patel from B Riley Securities. Your line is now live.
Yeah, Hey, good morning, and thanks for taking the question.
First for the additional updates that you expect to report later this quarter I believe you said.
How many more months of follow up should we expect for sort of the Oh truthful.
So with Pds.
Oh, you're talking to the <unk> two trial pathway to that correct.
Yeah.
Yes, so I am not privy to the clinical data, but I am hopeful that when we provide the updates later this.
This quarter, we will hopefully have updates on the 12 month overall survival and hopefully also have an update on the 24 month overall survival.
Those would be the two key updates that I would expect especially since those were key for design of the phase III clinical trial as you know the FDA is most interested in the overall survival and that's how the trial has been powered so those would be two key two key updates that I would be hopeful that we get.
At the end of the quarter.
Okay.
And then based on your.
Expectations.
Enrolling 90 to 100 sites in the phase III.
Assuming let's assume you start in the fourth quarter.
When would you expect the interim analysis and the primary endpoint as well.
Yeah.
So the interim and the primary endpoint for the trial overall survival. The planned interim analysis will be conducted after enrollment is complete and after a pre specified number of events have occurred. So since this endpoint is overall survival events will be death death events and a certain number of death events.
Have to occur to meet either the interim endpoints all of that.
While the final.
Endpoint and so really the enrollment projections were informed by our CRO feasibility analysis and they estimate.
About 18 to 24 month accrual period pending the actual enrollment rate and actual occurrence of these of these events right. So it's not there is not very easy to predict exactly when that time will occur, but the initial interim endpoint will be right after that.
Completed enrollment for the trial, so that could be anywhere between 18 to 24 months accrual period.
Okay perfect. Thanks, very much thanks for taking the question.
Welcome.
Thank you I just a reminder that star one to be placed in the question queue. Our next question is coming from Leland <unk> from Oppenheimer. Your line is now live.
Alright, thanks for taking our questions Hum I'm wondering Franklin Laura and what your view may be an accelerated.
Accelerated approval potential for.
P D S I wonder woman and the versatile O three.
Study you know following the FDA draft guidance that came out in March as you maybe aware.
With recommendations on development of drugs for.
The accelerated approval in oncology.
Randomized trials, such as versatile L. Three.
Could use the or.
As a sensible endpoint for affordability approvals, so given the robust responses you've seen.
So far in that population.
Uh huh.
Wondering if there may be a an opportunity for you to submit earlier ahead of the mature OS data and then use the O S data from over three as confirmation of.
Thanks.
I'll take a stab at it and then I'll also hand over to Loren to add to them.
My response, but I think.
As you know, we do have fast track designation and we would like to take advantage of that to have more frequent discussions with the FDA as the data becomes available.
We do understand that.
Currently the <unk> zero zero to date as extreme extremely encouraging and we are hopeful that if as we get to the interim data points. If the data looks anything close to what we see and currently with burst out 002 that will have the opportunity to discuss an accelerated approval with the F. D. A.
Even though overall survival is the primary end point, we also do have secondary endpoints such as.
<unk> objective response rates and PFS that we will be monitoring, but in head and neck cancer specific need the FDA made it very clear to us that since objective response rates have not really correlated with overall survival.
They are primarily interested in overall survival in head and neck cancer right and so that's why we powered this trial specifically for overall survival, but we will definitely take advantage of the fast track to have discussions with the FDA earlier honest the data.
Begins and continues to emerge.
Laurent anything you'd like to add to that.
Yes, the only thing I'd like to Echo Leland is that ultimately.
With accelerated approval like you mentioned a confirmatory trial is required so while first how's your tree. It's powered for the primary endpoint of overall survival. Once we have our final data cut in fault block from versatile deals you're too next year and also.
Have those final overall.
Overall survival rates for 12 months and 24 months as long as the objective response rates that would be another opportunity for discussions with the agency in terms of.
Additional accelerated approval discussion.
Oh.
Okay. That's that's helpful and then.
To muck, one when might we see initial data from the block one study.
Oh well we.
We have actually started that study yet so at this point I will.
I will not provide any timeline as to when we're going to see data and we are hopeful that we will file the IND.
By the end of this calendar year, which will allow us to get the clinical trial going public probably by early next year and so it's it's once we have more clarity on exactly what the clinical design is going to look like and we will be able to provide more information on.
When we should expect to see data so.
Hopefully hopefully on the next call, we'll have some more clarity clarity around that question.
Alright, thanks for taking the questions.
You're welcome.
Thank you. Your next question is coming from Robert Leboyer from Noble capital markets. Your line is now live.
Good morning, just one more follow up question on the design of versatile O three and in the interim analysis.
OS and PFS had been mentioned previously is PFS.
Still going to be an interim analysis.
Factor or endpoint that you can discuss with the FDA.
We will certainly be collecting the PFS inflammation, but the both the interim and the.
Final endpoints have been powered for overall survival.
Okay.
And one one question on the Triple combination.
You had mentioned that.
The design of the phase III was in progress any timing on that.
The submission of the 90.
For that for the start of the phase III.
So with that trial, specifically, we are waiting to get this this is going to be as I mentioned in patients checkpoint refractory head and neck cancer.
And checkpoint refractory head and neck cancer is that indication that we're evaluating in the second of the burst styles at zero two study.
And so absolutely as we mentioned on the last call. We expect that this quarter, we will be obtaining initial information from the first 21 patients who are being treated the first 21 checkpoint refractory head and neck cancer patients in diverse styles soon resume with two trial, primarily what we're looking for from that trial is overall survival.
And how it impacts and how treat additional pdfs, a one to one to conclude or may allow those patients to respond and continuing to survive that information is going to be critical together with the information we have from the triple combination trial to design. The final what we intend and hope to be a registrational.
Eddie.
One one of the things we will do with that design is something very similar to what we did with keytruda really maximize our interactions with the FDA get the Fda's feedback, we would like to understand what key elements that FDA would like to see in that trial to allow it to be a registrational trial right. Now so that's the interaction that we expect to be having with the F. D. A.
Probably starting later and later this year and so based upon those interactions and getting a really good understanding of what they would like to see in that trial to make it Registrational. We'll then be able to then project exactly when we stopped them.
But we would like to start initiate dose get the initial protocol down and stop those interactions with the FDA before the end of this year.
Okay. Thank you very much.
You're very welcome.
Thank you. Your next question is coming from James Molloy from Alliance Global Partners. Your line is now live.
Hello. This is last year you all calling from generally thank you for taking the questions.
So for the phase three breast atop all three trial with it being set to be initiated by the end of the year.
If it's not too early to tell when do you think you might complete enrollment here or.
Announced a fresh look our interim data.
Okay.
That's it.
As we discussed earlier the.
That timing is we expected based upon what the potential enrollment projections are and so we looked at what our CRM project have enrollment could potentially be for the various sites and also based upon the actual accrual.
And occurrence of the events that we expect to see for the fall, we anticipate that enrollment could take anywhere between 18 to 24 months to be completed.
And at that point, we would then have our first interim analysis.
Got it and then also for the NCI led a phase two trial of <unk> 301, when might we got additional data for this trial. Following the cytokine meeting that's going to be held this October and some of the other timelines here as well.
Hi, Mark I'll hand that question over to Lauren since you have some more information on that trial.
So as it relates to the NCI Triple combination study that examines the P. P. S O.
You know one and.
I think long I think backwards the Docetaxel trial.
Oh, Okay I I thought there was an interesting updated data. So I just wanted to highlight the fact that there will be updated survival data before the end of this quarter and then following the cytokines meeting presentation I think there will be additional discussions in term.
Further expansion of the study at the dose levels of P. D. S O 301, and Docetaxel that yielded optimum tolerant tolerability as well as.
Immune responses that are being examined and that will be presented in.
2023.
Okay.
Got it thank you for taking the questions.
Thank you we've reached end of our question and answer session I'd like to turn the floor back over for any further or closing comments.
Well, thank you very much Lauren and mass into our attendees. We very much appreciate you joining our second quarter earnings conference call. Today. This quarter's progress has been truly exciting and we remain enthusiastic about what lies ahead for the rest of the year.
Before concluding the call I would like to mention that we are planning a key opinion leader event in the near future. The webcast will include experts who will provide their perspective on PD. It's a 101 any data updates and its potential in the treatment of advanced head and neck cancer.
Please look out for more details as we get closer to the event.
You have seen from our press releases and as I have reiterated here on this call. We are excited to share that many data readouts that are on the horizon and that holds significant promise and potential value to our investors we.
We have made great strides in the path to achieve our goal of advancing a paradigm shift in the way head and neck cafes treated with a potentially well tolerated safe and effective treatment that extend the survival of advanced head and neck cancer patients.
We strongly strongly believes that in the very near future. These patients who have a critical unmet medical need.
Live longer and have a higher quality of life as a result of the work we're doing here today.
Thank you very much for your continued support and we look forward to updating you on our progress. Thanks a lot.
Thank you that does conclude today's teleconference. Webcast. You may disconnect. Your lines at this time and have a wonderful day, we thank you for your participation today.
Yeah.